Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Vibrio cholerae
Valneva UK Ltd
J07AE01
Vibrio cholerae
Oral suspension
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 14040000; GTIN: 5060025630540
1 PACKAGE LEAFLET: INFORMATION FOR THE USER DUKORAL SUSPENSION AND EFFERVESCENT GRANULES FOR ORAL SUSPENSION Cholera vaccine (inactivated, oral) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS VACCINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, nurse or pharmacist. - This vaccine has been prescribed for you only. Do not pass it on to others. - If you get any side effects, talk to your doctor, pharmacist or nurse. . This includes any possible side effects not listed in this leaflet. See Section 4. - Make sure to mix the vaccine with buffer solution as described in this leaflet. See Section 3. WHAT IS IN THIS LEAFLET : 1. What Dukoral is and what it is used for 2. What you need to know before you use Dukoral 3. How to use Dukoral 4. Possible side effects 5 How to store Dukoral 6. Contents of the pack and other information 1. WHAT DUKORAL IS AND WHAT IT IS USED FOR Dukoral is an oral vaccine against cholera that stimulates the immunological defence in the gut. The vaccine protects adults and children from 2 years of age against cholera. Dukoral causes your body to produce its own protection against cholera. After getting the vaccine, your body will make substances called antibodies, which fight the cholera bacteria and toxin that cause diarrhoea. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DUKORAL DO NOT USE DUKORAL • if you are allergic to any ingredient of the vaccine or to formaldehyde. • if you have an acute stomach disorder or infection with fever (vaccination should be delayed). WARNINGS AND PRECAUTIONS Talk to your doctor before taking Dukoral • if you take a medical treatment that affects the immune system • if you have a disease of the immune system (including AIDS). The vaccine may provide you with a lower level of protection than it does for people with healthy immune systems. The vaccine does not provide complete protection and it is important to adhere to dietary and hygien Olvassa el a teljes dokumentumot
OBJECT 1 DUKORAL SUSPENSION AND EFFERVESCENT GRANULES FOR ORAL SUSPENSION, CHOLERA VACCINE (INACTIVATED, ORAL) Summary of Product Characteristics Updated 07-Dec-2015 | Valneva UK Limited 1. Name of the medicinal product Dukoral suspension and effervescent granules for oral suspension Cholera vaccine (inactivated, oral) 2. Qualitative and quantitative composition Each dose of vaccine suspension (3 ml) contains: A total of 1.25x10 11 bacteria of the following strains: _Vibrio cholerae_ O1 Inaba, classical biotype (heat inactivated) 31.25x10 9 bacteria* _Vibrio cholerae_ O1 Inaba, El Tor biotype (formalin inactivated) 31.25x10 9 bacteria* _Vibrio cholerae_ O1 Ogawa, classical biotype (heat inactivated) 31.25x10 9 bacteria* _Vibrio cholerae_ O1 Ogawa, classical biotype (formalin inactivated) 31.25x10 9 bacteria* Recombinant cholera toxin B subunit (rCTB) 1 mg (produced in _V. cholerae_ O1 Inaba, classical biotype strain 213.) * Bacterial count before inactivation. Excipients: Sodium dihydrogen phosphate dihydrate 2.0 mg, disodium hydrogen phosphate dihydrate 9.4 mg, sodium chloride 26 mg, sodium hydrogen carbonate 3600 mg, sodium carbonate anhydrous 400 mg, saccharin sodium 30 mg, sodium citrate 6 mg. One dose contains approximately 1.1 g sodium. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Suspension and effervescent granules for oral suspension. The suspension, supplied in a bottle is whitish. The effervescent granules, supplied in a sachet, are white. 4. Clinical particulars 4.1 Therapeutic indications Dukoral is indicated for active immunisation against disease caused by _Vibrio cholerae_ serogroup O1 in adults and children from 2 years of age who will be visiting endemic/epidemic areas. The use of Dukoral should be determined on the basis of official recommendations taking into consideration the variability of epidemiology and the risk of contracting disease in different geographical areas and travelling conditions. Dukoral should not replace standard protective measures. In the e Olvassa el a teljes dokumentumot